510(k) · Cleared
ClearedJulva Velvé Water-Based Personal Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Golden Isles Medical, Inc. · NUC Lubricant, Personal
Cleared on Apr 16, 2026 as substantially equivalent to K211998 (Good Clean Love, Inc., 2021) after a 118-day review. Its family tree reaches back 6 generations to 1981.
- Decided
- Apr 16, 2026
- Review
- 118 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K810310 (1981). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 5 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 4 generations backK033076 Lifestyles Liquid Personal LubricantAnsell Healthcare, Inc. · 2003
- 3 generations backK070587 Elegance Woman's LubricantJulie Williams, Pa-C · 2008
- 2 generations backK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- 1 generation backK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
- This deviceK254101 Julva Velvé Water-Based Personal LubricantGolden Isles Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −5 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −4 | K033076 | Lifestyles Liquid Personal Lubricant | Ansell Healthcare, Inc. | 2003 | — |
| −3 | K070587 | Elegance Woman's Lubricant | Julie Williams, Pa-C | 2008 | — |
| −2 | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| −1 | K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 | — |
| 0 (this device) | K254101 | Julva Velvé Water-Based Personal Lubricant | Golden Isles Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NUC device
- #1 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211998 | Desnuda ReflectSummary page 5…21 CFR §884.5300 Regulatory Class: Class II Product Code: NUC (lubricant, personal) 5. Predicate Devices Desnuda Reflect - K211998 The predicate device has not been subject to a design‐related recall. 6. Device Description Julva Velvé Water-Based Person… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 45 years and passes through 7 companies; a new generation was cleared every 7.4 years on median.
- None of the 13 ancestors has a recall.
- 4 other devices also cite its predicate K211998.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NUC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUC
221in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUC
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUC
13in 2025
MAUDE reports naming product code NUC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 150 | 0 | 0 |
| 2008 | 7 | 271 | 1 | 6 |
| 2009 | 2 | — | 1 | 13 |
| 2010 | 4 | 124 | 0 | 2 |
| 2011 | 2 | — | 0 | 3 |
| 2012 | 6 | 269 | 0 | 6 |
| 2013 | 11 | 205 | 3 | 5 |
| 2014 | 11 | 264 | 0 | 14 |
| 2015 | 21 | 251 | 0 | 8 |
| 2016 | 14 | 181 | 0 | 14 |
| 2017 | 14 | 175 | 0 | 19 |
| 2018 | 15 | 114 | 0 | 6 |
| 2019 | 13 | 150 | 0 | 8 |
| 2020 | 19 | 180 | 0 | 2 |
| 2021 | 20 | 143 | 0 | 7 |
| 2022 | 14 | 112 | 0 | 7 |
| 2023 | 13 | 159 | 0 | 15 |
| 2024 | 6 | 178 | 0 | 13 |
| 2025 | 11 | 221 | 0 | 13 |
| 2026 | 12 | 104 | 0 | — |
What is it indicated for?
Julva Velvé Water-Based Personal Lubricant is a water-based personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. Julva Velvé Water-Based Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254101: Julva Velvé Water-Based Personal Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254101
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026